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CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Accuray Incorporated
ClinicalTrials.gov Identifier:
NCT00643994
First received: March 20, 2008
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.


Condition Intervention Phase
Prostate Cancer
Prostatic Cancer
Prostate Neoplasms
Prostatic Neoplasms
Cancer of the Prostate
 Radiation: CyberKnife Stereotactic Radiosurgery
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Accuray Incorporated:

Primary Outcome Measures:
  • To estimate, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities observed following CyberKnife treatment for prostate cancer. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • To determine the rate of biochemical Disease-Free Survival (bDFS), using the Phoenix and ASTRO definitions, following CyberKnife treatment. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the rates of local failure, distant failure, disease-free survival, disease-specific survival, overall survival and quality of life following CyberKnife treatment in prostate cancer patients. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 298
Study Start Date: December 2007
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CyberKnife Stereotactic Radiosurgery Radiation: CyberKnife Stereotactic Radiosurgery
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
Other Name: CyberKnife

Detailed Description:

The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must be at least 18 years of age
  • Histologically proven prostate adenocarcinoma
  • Patients belonging in one of the following risk groups:

Low: CS T1b-T2a and Gleason 2-6 and PSA ≤ 10, or Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10 or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml or Gleason 7 and PSA ≤ 10 ng/ml

  • Prostate volume: ≤ 100 cc
  • ECOG performance status 0-1

Exclusion Criteria:

  • Prior prostatectomy or cryotherapy of the prostate
  • Prior radiotherapy to the prostate or lower pelvis
  • Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
  • Chemotherapy for a malignancy in the last 5 years
  • History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
  • Hormone ablation for two months prior to enrollment, or during treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00643994

  Show 23 Study Locations
Sponsors and Collaborators
Accuray Incorporated
Investigators
Study Chair: Robert Meier, MD Swedish Cancer Center
Study Chair: Irving Kaplan, MD Beth Israel Deaconess Medical Center
Study Chair: Martin Sanda, MD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
Accuray Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Accuray Incorporated
ClinicalTrials.gov Identifier: NCT00643994     History of Changes
Other Study ID Numbers: ACCP001.3
Study First Received: March 20, 2008
Last Updated: April 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Accuray Incorporated:
Prostate Cancer
CyberKnife
Stereotactic Radiosurgery
Radiotherapy
 Radiation
Prostate Tumor
Prostate Surgery

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013